Duns Number:090125555
Device Description: KODA Disposable Nitrile Exam Grade Gloves, Powder Free, CHEM-FEN-DERM BLACK 3.5MIL 10/90-X KODA Disposable Nitrile Exam Grade Gloves, Powder Free, CHEM-FEN-DERM BLACK 3.5MIL 10/90-XX
Catalog Number
GL-NCF235BKFXX
Brand Name
KODA
Version/Model Number
GL-NCF235BKFXX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
259372db-09b6-462b-95e6-91633c6bfa78
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 20, 2020
Package DI Number
10075289122559
Quantity per Package
10
Contains DI Package
00075289122552
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box